tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2024 Dec 31;20(1):2410574.
doi: 10.1080/21645515.2024.2410574. Epub 2024 Oct 14. A novel orf virus vector-based COVID-19 booster vaccine shows cross-neutralizing activity in the absence of anti-vector neutralizing immunity
Ute Klinkardt[SUP] 1 [/SUP], Mirjam Schunk[SUP] 2 [/SUP], John Ervin[SUP] 3 [/SUP], Christoph Schindler[SUP] 4 [/SUP], Danny Sugimoto[SUP] 5 [/SUP], Bruce Rankin[SUP] 6 [/SUP], Ralf Amann[SUP] 7 [/SUP], Martina Monti[SUP] 8 [/SUP], Anna Kutschenko[SUP] 4 [/SUP], Carsten Schumacher[SUP] 4 [/SUP], Kristina Huber[SUP] 2 [/SUP], Andreas Zeder[SUP] 2 [/SUP], Nelli Heikkila[SUP] 9 [/SUP], Arnaud M Didierlaurent[SUP] 9 [/SUP], Sylvia E Schwarz[SUP] 1 [/SUP], Madiha Derouazi[SUP] 1 [/SUP]
Affiliations
Next-generation COVID-19 vaccines are being developed to expand the breadth of coverage against existing and future variants and to extend the duration of protection. Prime-2-CoV_Beta is an orf virus (ORFV) based multi-antigen COVID-19 vaccine that co-expresses Spike (S) and Nucleocapsid (N) antigens. The safety and immunogenicity of Prime-2-CoV_Beta is investigated in a phase 1 first-in-human (FIH) dose-finding trial (ORFEUS study, ClinicalTrials.gov: NCT05367843). Participants of two age groups (18-55 and 65-85 years) who previously completed at least two doses of mRNA vaccines were enrolled and sequentially assigned to different dose groups to receive one intramuscular dose of 3 × 10[SUP]5[/SUP], 3 × 10[SUP]6[/SUP], 1.5 × 10[SUP]7[/SUP], or 3 × 10[SUP]7[/SUP] plaque-forming units (PFU) of Prime-2-CoV_Beta on day 1 and a second dose on day 29. Here, we report safety and immunogenicity data collected up to 6 months after the first study vaccination. Prime-2-CoV_Beta is safe and well tolerated and elicits immune responses at higher dose levels in participants aged 18-55. A single dose of 3 × 10[SUP]7[/SUP] PFU boosted binding and cross-neutralizing antibody responses that are maintained through 6 months after the first booster vaccination. Polyfunctional S-specific CD4+ and CD8+ T cell responses are observed after vaccination. No pre-existing or vaccine-induced neutralizing anti-vector antibodies are detected. Our findings highlight the potential of the ORFV vector as a safe platform for future vaccine design, which provides the ability to deliver multiple antigens and allows for repeat immunization.
Keywords: COVID-19; ORF virus-vector; SARS-CoV-2 variants; booster vaccine; first-in-human trial; immunogenicity; safety.
. 2024 Dec 31;20(1):2410574.
doi: 10.1080/21645515.2024.2410574. Epub 2024 Oct 14. A novel orf virus vector-based COVID-19 booster vaccine shows cross-neutralizing activity in the absence of anti-vector neutralizing immunity
Ute Klinkardt[SUP] 1 [/SUP], Mirjam Schunk[SUP] 2 [/SUP], John Ervin[SUP] 3 [/SUP], Christoph Schindler[SUP] 4 [/SUP], Danny Sugimoto[SUP] 5 [/SUP], Bruce Rankin[SUP] 6 [/SUP], Ralf Amann[SUP] 7 [/SUP], Martina Monti[SUP] 8 [/SUP], Anna Kutschenko[SUP] 4 [/SUP], Carsten Schumacher[SUP] 4 [/SUP], Kristina Huber[SUP] 2 [/SUP], Andreas Zeder[SUP] 2 [/SUP], Nelli Heikkila[SUP] 9 [/SUP], Arnaud M Didierlaurent[SUP] 9 [/SUP], Sylvia E Schwarz[SUP] 1 [/SUP], Madiha Derouazi[SUP] 1 [/SUP]
Affiliations
- PMID: 39397784
- DOI: 10.1080/21645515.2024.2410574
Next-generation COVID-19 vaccines are being developed to expand the breadth of coverage against existing and future variants and to extend the duration of protection. Prime-2-CoV_Beta is an orf virus (ORFV) based multi-antigen COVID-19 vaccine that co-expresses Spike (S) and Nucleocapsid (N) antigens. The safety and immunogenicity of Prime-2-CoV_Beta is investigated in a phase 1 first-in-human (FIH) dose-finding trial (ORFEUS study, ClinicalTrials.gov: NCT05367843). Participants of two age groups (18-55 and 65-85 years) who previously completed at least two doses of mRNA vaccines were enrolled and sequentially assigned to different dose groups to receive one intramuscular dose of 3 × 10[SUP]5[/SUP], 3 × 10[SUP]6[/SUP], 1.5 × 10[SUP]7[/SUP], or 3 × 10[SUP]7[/SUP] plaque-forming units (PFU) of Prime-2-CoV_Beta on day 1 and a second dose on day 29. Here, we report safety and immunogenicity data collected up to 6 months after the first study vaccination. Prime-2-CoV_Beta is safe and well tolerated and elicits immune responses at higher dose levels in participants aged 18-55. A single dose of 3 × 10[SUP]7[/SUP] PFU boosted binding and cross-neutralizing antibody responses that are maintained through 6 months after the first booster vaccination. Polyfunctional S-specific CD4+ and CD8+ T cell responses are observed after vaccination. No pre-existing or vaccine-induced neutralizing anti-vector antibodies are detected. Our findings highlight the potential of the ORFV vector as a safe platform for future vaccine design, which provides the ability to deliver multiple antigens and allows for repeat immunization.
Keywords: COVID-19; ORF virus-vector; SARS-CoV-2 variants; booster vaccine; first-in-human trial; immunogenicity; safety.